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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name assay, nucleic acid amplification, bacillus anthracis
510(k) Number K072631
Device Name JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123
Applicant
IDAHO TECHNOLOGY, INC.
390 Wakara Way
Salt Lake City,  UT  84108
Applicant Contact BETH LINGENFELTER
Correspondent
IDAHO TECHNOLOGY, INC.
390 Wakara Way
Salt Lake City,  UT  84108
Correspondent Contact BETH LINGENFELTER
Regulation Number866.3045
Classification Product Code
NHT  
Date Received09/18/2007
Decision Date 12/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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